ApTask Global Workforce (AGW) is seeking a Validation Engineer Senior with a technology company. This is a 12+ month contract opportunity with our client located in Holly Springs, NC. This is an onsite position.Responsibilities: - Lead the execution of all Cleaning Validation activities (CV/SIP PQ/CHT/SHT studies), including protocol generation, field execution, data retrieval/verification, and sample management using Kneat
- Support a non-traditional work schedule based on project and business needs, including potential nights or weekends
- Perform on-floor CV execution and sampling, providing technical support to cleaning activities
- Design and develop cleaning procedures for new products and manufacturing equipment
- Conduct cleaning validation studies, including sampling, testing, and data analysis
- Investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations, and out-of-specification results
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering
- Train manufacturing and QC/QA personnel on cleaning validation documentation
- Support the development of the periodic cleaning monitoring program
- Lead and support continuous improvement by identifying and implementing projects to improve cleaning times through CIP Optimization
- Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures
Requirements: - Must meet one of the following educational and experience requirements:
- Doctorate degree
- Master's degree and 2 years of experience
- Bachelor's degree and 4 years of experience
- Associate's degree and 8 years of experience
- High school diploma / GED and 10 years of experience
- 8+ years of overall experience with field execution experience
- Proficient with Kneat software
- Demonstrated track record of leading and executing cleaning validation studies and knowledge of the CV lifecycle
- Proficient with CIP/SIP cycles and process understanding to drive execution of validation deliverables
- Willingness to work a non-traditional shift, off-shift, weekends, and holidays to support cleaning validation activities as needed
- Demonstrated proficiency in utilizing PI for run trending analysis
- Effective communication and collaboration skills to work across teams
Desired skills: - Project Management experience
- Experience with troubleshooting deviation, CAPA, and change control management
- Ability to support investigational studies as needed
Pay range: Up to $66.43 per Hour
Only candidates available and ready to work directly as ApTask Global Workforce (AGW) employees will be considered for this position.
If you have the described qualifications and are interested in this exciting opportunity, please apply! ApTask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
Never miss an opportunity! Create an alert based on the job you applied for.